MAUDE Adverse Event Report: EUROSETS S.R.L. ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number US5062

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/03/2023

Event Type  malfunction  

Manufacturer Narrative

There was no patient involved in this event.The pma# provided is associated with the device¿s most recent approval.No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is complete.

Event Description

It was reported that the oxygenator had fluid leaking from the bottom.The leak was detected during initial setup and priming and was not used on a patient.Flow rates were noted to vary during priming, but were not greater than 3 liters per minute (lpm).No pressures were monitored during priming.The oxygenator was removed from use.

Manufacturer Narrative

Manufacturer's investigation conclusion: functional testing of the returned oxygenator by the external manufacturer (eurosets) confirmed an oxygenator leak due to fiber breakage; however, a specific root cause for the fiber breakage could not be conclusively determined through this evaluation.The oxygenator was returned to abbott where an initial visual inspection was performed.Visual inspection of the oxygenator revealed no obvious damage.It was noted that some priming fluid remained in the blood pathway of the device.Fluid was also noted in the top and bottom housing.The oxygenator was forwarded to eurosets for technical analysis.The oxygenator was placed on a mock loop with physiological water.The oxygenator was filled using a peristaltic pump at 6 lpm and remained in the mock loop for 10 minutes.A slow drip in the lower part of the oxygenator was confirmed.The device was sectioned by removing the lower housing, refilled with water, and pressurized.The point of loss occurred due to the fiber breakage of the last winding of fibers near the blood outlet port.The device history record for the oxygenator, lot # 7559308, was reviewed by the external manufacturer and showed that all tests from the production process were compliant with the technical specifications.Devices are required to pass manufacturing inspections and specifications prior to release, and no abnormalities were documented which would cause or contribute to the reported occurrence.This device passed all required testing.Eurosets confirmed that 100% of the oxygenators produced are tested to detect eventual leakages using a pressure of 150 kpa (kilopascals) which is 1.5 times the maximum blood pathway pressure indicated on the ifu (instructions for use).Devices that exhibit leaks are discarded prior to distribution.Eurosets determined that the issue occurred after eurosets¿ manufacturing and test phases.The eurosets amg pmp instructions for use (ifu) is currently available.Under the list of warnings, the ifu warns that during use, a spare oxygenator must always be available and also warns that the device has to be carefully and continuously checked by qualified healthcare professionals throughout the procedure.Also, under the section titled ¿set up¿, the ifu warns to ¿carry out a visual inspection and carefully check the device before use.Transport and/or storage conditions other than those prescribed may have caused damage to the device.¿ under the section titled ¿oxygenator replacement¿, this document states that a spare oxygenator must always be available during perfusion.After 6 hours of use with blood or if particular situations occur, which may lead the person responsible for perfusion to determine the safety of the patient may be compromised (insufficient oxygenator performance, leaks, abnormal blood parameters, etc.), follow the procedure outlined in the ifu for oxygenator replacement.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EUROSETS S.R.L.; strada statale 12, n°143; medolla, modena 41036 ; IT 41036
• Manufacturer (Section G): EUROSETS S.R.L.; strada statale 12, n°143; medolla, modena 41036 ; IT 41036
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 17372031
• MDR Text Key: 320030765
• Report Number: 3003752502-2023-02394
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 08034013782020
• UDI-Public: 08034013782020
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: US5062
• Device Catalogue Number: US5062
• Device Lot Number: 7559308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1